EP2688629B1 - Urinsammelanordnung und verfahren zur herstellung einer solchen anordnung - Google Patents

Urinsammelanordnung und verfahren zur herstellung einer solchen anordnung Download PDF

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Publication number
EP2688629B1
EP2688629B1 EP12713441.9A EP12713441A EP2688629B1 EP 2688629 B1 EP2688629 B1 EP 2688629B1 EP 12713441 A EP12713441 A EP 12713441A EP 2688629 B1 EP2688629 B1 EP 2688629B1
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EP
European Patent Office
Prior art keywords
catheter
urine collection
collection bag
attachment port
barrel portion
Prior art date
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Application number
EP12713441.9A
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English (en)
French (fr)
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EP2688629A1 (de
Inventor
Daniel O'brien
Martin P. Creaven
Michael Murray
Bent Jensen
David Hannon
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Hollister Inc
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Hollister Inc
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Publication of EP2688629A1 publication Critical patent/EP2688629A1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/451—Genital or anal receptacles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/22—Immersing contents in protective liquids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B7/00—Closing containers or receptacles after filling
    • B65B7/02—Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/002—Packages specially adapted therefor ; catheter kit packages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0111—Aseptic insertion devices
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

Definitions

  • the present disclosure relates generally to urine collection assemblies and, more particularly, to a closed urine collection assembly and method of manufacturing a closed urine collection assembly utilizing a conventional catheter having a tapered funnel.
  • Intermittent urinary catheterization is a good option for many users who suffer from various abnormalities of the urinary system.
  • a commonly encountered situation is where single use, individually packaged, sterile catheters are used.
  • An important criterion for any single use product is the cost of the product, i.e., a less expensive product is desired and valued.
  • catheters it is also common for catheters to be provided with a surface treatment using a lubricant to reduce friction in order to allow for easier and less traumatic insertion of the catheter.
  • a lubricant to reduce friction in order to allow for easier and less traumatic insertion of the catheter.
  • catheters for the drainage of urine from the bladder which have lubricated surfaces, i.e., gel lubricated catheters and hydrophilic coated catheters.
  • the gel lubricated catheters are made easier to insert by application to the catheter surface of a water-based gel that can be applied by the user or health care provider, or more conveniently, it can be supplied with the packaged catheter.
  • a system is provided with the packaged catheter to apply the gel to the surface of the catheter. This system may be one where the gel is placed on the catheter surface before or during the catheter packaging operation or one where the gel is applied to the catheter surface as the catheter is inserted by the user or health care provider.
  • the catheter In a hydrophilic coated catheter, the catheter is provided with a thin hydrophilic coating which is adhered to the outer surface of the catheter. When this coating is activated by swelling in contact with a hydrating agent such as water, it provides a surface having a lubricious and extremely low coefficient of friction.
  • a sterile, individually packaged single use catheter is provided in a dry state, and the user or health care provider opens the package and pours water into the package to hydrate the coating. After doing so, the user or health care provider would wait 30 seconds and remove the catheter from the package ready for insertion.
  • a more recent version of the hydrophilic coated catheter is where the catheter is provided in a package that already contains enough loose liquid water to cause it to be fully immersed. For this product, the user simply opens the package and removes the catheter ready for insertion without the need to add water and wait 30 seconds.
  • Other products provide the amount of liquid water necessary for immersion of the catheter, e.g., in a separate compartment of the package. With these products, the separate compartment is opened to allow the liquid immersion water to enter the catheter-containing chamber for direct contact with the hydrophilic coated surface.
  • the user may be asked to manipulate the package to bathe the catheter surface in the hydrating liquid in order to activate the hydrophilic coating on the catheter surface before the catheter is removed from the package ready for insertion by the user or health care provider.
  • WO2008103644 discloses a device for connecting a catheter assembly to a collection receptacle.
  • US2008172042 discloses a urinary catheter assembly having a catheter, a sheath enclosing an insertable portion of the catheter, and a free end partially open to allow fluid communication between the lumen of the sheath and an environment outside the sheath.
  • WO 2007/050685 A2 discloses a pre-wetted intermittent catheter apparatus.
  • the disclosure is directed, according to an example not forming part of the invention, to a urine collection assembly comprising a catheter and a urine collection bag.
  • the catheter has a proximal insertion end and a distal end having a portion of a tapered funnel integrally associated therewith.
  • the portion of the tapered funnel associated with the distal end of the catheter comprises only a cylindrical barrel portion.
  • the urine collection bag has a cylindrical attachment port and the cylindrical barrel portion is sealed in the cylindrical attachment port.
  • urine being drained from the bladder by the catheter can pass directly into the urine collection bag through a sealed joint between the catheter and the urine collection bag.
  • the urine collection assembly including the catheter and urine collection bag is provided in a packaged, ready-to- use condition.
  • the urine collection bag is formed of a flexible sheet material and the attachment port is sealed into the periphery of the urine collection bag.
  • the flexible sheet material can advantageously comprise two generally rectangular sheets of EVA/polyethylene film sealed substantially entirely about the peripheral edges thereof except where the attachment port is located as will be explained in greater detail below.
  • the cylindrical attachment port is preferably a co-extruded tube which is formed to have an EVA outer surface and a PVC inner surface.
  • the cylindrical barrel portion which is also conventionally formed of PVC is preferably sealed to the inner surface of the co-extruded tube by spin welding.
  • the catheter is disposed externally of the urine collection bag and includes a hydrated hydrophilic outer surface.
  • the catheter can also include an introducer at or near the proximal insertion end of the catheter and a sleeve substantially covering the catheter.
  • the urine collection assembly preferably includes an anti-reflux valve sealed to the cylindrical attachment port within the urine collection bag.
  • the invention is directed to a method of manufacturing a packaged ready-to-use urine collection assembly according to claim 1.
  • the method includes the steps of forming the urine collection bag of a flexible sheet material and sealing the attachment port into the sheet material. It may also advantageously include the step of using two sheets of EVA/polyethylene film for the flexible sheet material and sealing the two sheets about the peripheral edges thereof. It may also preferably include the step of providing a co-extruded tube having an EVA outer surface and a PVC inner surface for the cylindrical attachment port.
  • the method may advantageously include the cylindrical barrel portion being formed of PVC and the sealing step being performed by spin welding.
  • the spin welding step is preferably performed by holding the catheter in a stationary position and spinning the urine collection bag relative to the catheter.
  • the spin welding step may advantageously include spinning the urine collection bag relative to the catheter at a rotational speed of between 1900 and 3000 RPMs.
  • the spin welding step preferably includes spinning the urine collection bag relative to the catheter for between 14 and 16 revolutions.
  • the method further includes the step of providing the urine collection bag in a generally rectangular shape, folding the urine collection bag at least once generally perpendicular to the direction of the catheter, performing the spin welding step, folding the urine collection bag at least once in the direction of the catheter, and banding the urine collection bag in a folded condition.
  • the method can include the step of providing an introducer at or near the proximal insertion end of the catheter and a sleeve substantially covering the catheter. Additionally, the method can include the step of sealing an anti-reflux valve to the cylindrical attachment port within the urine collection bag to prevent reverse urine flow into the catheter.
  • the reference numeral 10 designates generally a urine collection assembly in accordance with the present disclosure.
  • the urine collection assembly 10 includes a catheter generally designated 12 having a proximal insertion end 14 and a distal end 16.
  • the distal end 16 has only a cylindrical barrel portion 18 of a tapered funnel such as 20 ( Fig. 4 ) integrally associated therewith.
  • the cylindrical barrel portion 18 of the tapered funnel 20 at the distal end 16 of the catheter 12 is best illustrated in the detailed views of Figs. 3A and 3B .
  • the urine collection assembly 10 also includes a urine collection bag generally designated 22 having a cylindrical attachment port 24.
  • the cylindrical barrel portion 18 is sealed within the cylindrical attachment port 24 ( Fig. 3 ) to provide a closed collection system. Accordingly, the urine collection assembly 10 permits urine drained from the bladder by the catheter 12 to pass through the cylindrical barrel portion 18 and into the urine collection bag 22.
  • the urine collection bag 22 can be formed of flexible sheet material with the attachment port 24 sealed into the sheet material.
  • the flexible sheet material can comprise two sheets of EVA/polyethylene film sealed about the peripheral edges thereof.
  • the cylindrical attachment port 24 can be a co-extruded tube formed to have an EVA outer surface and a PVC inner surface. Alternatively, it will be understood that other suitable materials now known or hereafter discovered may be suitable for use.
  • the flexible sheet material of the urine collection bag 22 is easy to seal substantially entirely about the peripheral edges thereof, and the cylindrical barrel portion 18 may suitably comprise a portion of a tapered funnel such as 20 which is conventionally formed of PVC.
  • the cylindrical barrel portion 18 and inner surface of the cylindrical attachment port 24 may be formed of PVC. Since these like materials are utilized and will be in confronting relation when the cylindrical barrel portion 18 is inserted into cylindrical attachment port 24 during manufacture of the urine collection assembly 10, it is possible to utilize spin welding to seal the cylindrical barrel portion 18 within the cylindrical attachment port 24 to these components together while eliminating the need for the use of adhesives or solvents that can produce harmful vapors.
  • the catheter 12 is disposed externally of the urine collection bag 22 in a ready-to-use position after the cylindrical barrel portion 18 has been sealed within the cylindrical attachment port 24.
  • the catheter 12 may advantageously include a hydrated hydrophilic outer surface to further enhance the desirability of the urine collection assembly 10 by ensuring it is ready-to use without any preliminary preparation.
  • the catheter 12 may include an introducer 26 at or near the proximal insertion end 14 of the catheter 12, and it may also include a sleeve 28 substantially covering the catheter 12 to facilitate no-touch handling.
  • the sleeve 28 may be made from polyurethane or other suitable materials now known or hereafter discovered.
  • the urine collection bag 22 can include an anti -reflux valve 30 sealed to the cylindrical attachment port 24.
  • Fig. 5 illustrates the peripheral seal 32 extending entirely about the periphery of two sheets of flexible material to form the urine collection bag 22.
  • the urine collection bag 22 may include two seal portions 32a and 32b in the region of the cylindrical attachment port 24. With this arrangement, it will be understood that the anti-reflux valve 30 can also be captured by one or both of the seal portions 32a and 32b.
  • the anti-reflux valve 30 may be formed of two flexible sheets of material advantageously comprising LDPE film.
  • it may be advantageous to tack or weld the two sheets or films together at a plurality of discrete locations such as 34.
  • the tacks or welds may be provided at locations opposite the cylindrical attachment port 24 in substantially equally spaced relation.
  • the discrete tacks or welds 34 are preferably evenly spaced along the edge 30a of the anti-reflux valve 30 opposite the cylindrical attachment port 24 and extend longitudinally in generally parallel relation to the axis of the cylindrical attachment port 24 to facilitate urine flow into the urine collection bag 22 but prevent reverse urine flow out of the urine collection bag 22, i.e., they form a nonreturn valve.
  • Fig. 5 also illustrates two further seals 32c and 32d which define an opening 36 to facilitate handling of the urine collection bag 22.
  • the urine collection bag 22 may be provided with volume indicia as at 38 indicative of the amount of urine collected therein.
  • the urine collection assembly 10 can be provided as a packaged, ready-to-use product. It can then include a gas impermeable package 40, illustrated after opening utilizing a tear strip 42. The catheter 12 and urine collection bag 22 are illustrated after they have been removed from the package 40 and are in a ready-to-use condition.
  • the urine collection bag 22 is preferably generally rectangular in shape. This permits it to easily be folded at least once generally perpendicular to the direction of the catheter 12 and at least once in the direction of the catheter 12 so that it can be rendered quite compact after folding as illustrated in Figs. 1 and 2 .
  • a band 44 can be used to hold it in a folded condition.
  • the urine collection assembly 10 can assume a long, narrow profile suitable for utilizing a long, narrow and compact package such as 40.
  • the invention is directed to a method of manufacturing a packaged ready-to-use urine collection assembly 10.
  • the method comprises the step of providing a catheter 12 having a proximal insertion end 14 and a distal end 16 wherein the catheter 12 can have a hydrophilic outer surface to be hydrated prior to use.
  • the distal end 16 of the catheter 12 is provided with a tapered funnel 20 ( Fig. 4 ) including a cylindrical barrel portion 18 and a conical portion 46 integrally associated therewith.
  • the method also comprises the step of cutting off the conical portion 46 of the tapered funnel 20 and leaving only the cylindrical barrel portion 18 of the tapered funnel 20 on the catheter 12.
  • the method further comprises the step of providing a urine collection bag 22 having a cylindrical attachment port 24 with an opening to receive the cylindrical barrel portion 18 in size for size fashion. It will be understood that due to tolerances there may be some slight size variation between the inside diameter of the cylindrical attachment port 24 and the outside diameter of the cylindrical barrel portion 18.
  • the cylindrical barrel portion 18 of the tapered funnel 20 is placed in the opening defined by the cylindrical attachment port 24 of the urine collection bag 22 in size for size fashion.
  • the method additionally comprises the step of sealing the cylindrical barrel portion 18 of the tapered funnel 20 within the opening defined by the cylindrical attachment port 24 of the urine collection bag 22.
  • the method according to the invention includes the step of providing a gas impermeable package 40 capable of receiving the catheter 12 and the urine collection bag 22 therein, the step of placing the catheter 12, the urine collection bag 22 and a hydrating agent into the gas impermeable package 40, and the step of sealing the gas impermeable package 40 with the catheter 12, the urine collection bag 22 and the hydrating agent therein to complete the ready-to-use assembly.
  • the method can include the steps of forming the urine collection bag 22 of a flexible sheet material and sealing the attachment port 24 into the sheet material. It can also include the step of using two sheets of EVA/polyethylene film for the sheet material and sealing the two sheets about the peripheral edges 32. It can also include the step of providing a co- extruded tube for the cylindrical attachment port 24 formed with an EVA outer surface and PVC inner surface.
  • the cylindrical barrel portion 18 of the tapered funnel 20 is formed of PVC and the cylindrical barrel portion 18 is sealed within the opening defined by the cylindrical attachment port 24 by spin welding. Still additionally, the spin welding step is advantageously performed by holding the catheter 12 in a fixed or stationary position and then causing the urine collection bag 22 to spin relative to the stationary catheter 12.
  • the spin welding step can include spinning the urine collection bag 22 relative to the catheter 12 at a rotational speed of between 1900 and 3000 RPMs, depending upon the size of the catheter, and spinning the urine collection bag 22 relative to the catheter 12 for between 14 and 16 revolutions, again depending upon the size of the catheter.
  • the step of providing a urine collection bag 22 may include providing it in a generally rectangular shape, folding the urine collection bag 22 at least once in the direction of the catheter 12, folding the urine collection bag 22 at least once generally perpendicular to the direction of the catheter 12, performing the spin welding step, again folding the urine collection bag 22 in the direction of the catheter 12, and banding the urine collection bag 22 with a band 44 in a folded condition for placement a package such as 40.
  • Figs. 7A-7e illustrate a urine collection bag folding process in accordance with the disclosure.
  • the urine collection bag 22 is laid flat in order to initiate the folding process ( Fig. 7A ), and the urine collection bag 22 is folded in half in the direction of the cylindrical attachment port 24 (and, thus, in the direction of the catheter) so the left edge 48 containing the cylindrical attachment port 24 meets the right edge 50 ( Fig. 7B ).
  • the bottom edge 52 of the urine collection bag 22 is folded up in a direction generally perpendicular to the cylindrical attachment port 24 (and, thus, generally perpendicular to the direction of the catheter) to touch the bottom of the cylindrical attachment port 24 and define a new bottom edge 52' after folding ( Fig. 7C ).
  • the top edge 54 of the urine collection bag 22 is folded down in a direction generally perpendicular to the cylindrical attachment port 24 (and, thus, generally perpendicular to the direction of the catheter) to meet the bottom edge 52' and define a new top edge 56 after folding ( Fig. 7D ).
  • the edges 54, 52' which meet at the bottom of the urine collection bag 22 in Fig. 7D are folded up in a direction generally perpendicular to the cylindrical attachment port 24 (and, thus, generally perpendicular to the direction of the catheter) to meet the top edge 56 after which the urine collection bag is ready for spin welding.
  • the urine collection bag can be folded in the direction of the catheter 12 as at 58 and 60 ( Figs. 1 and 2 ) and banded with a band 44 in the folded condition shown for placement in a package such as 40 ( Fig. 6 ).
  • Further aspects of the method can include the steps of providing an introducer 26 at or near the proximal insertion end 14 of the catheter 12 and a sleeve 28 substantially covering the catheter 12.
  • the method can also include the step of sealing an anti-reflux valve 30 at a location within the urine collection bag 22 to the cylindrical attachment port 24 and/or sealing the anti-reflux valve 30 to the urine collection bag 22 such as by the seals 32a and 32b.
  • the method can include the step of providing liquid water as the hydrating agent in the package 40 and including isolating the liquid water from the hydrophilic outer surface of the catheter.
  • the method still additionally includes the step of delaying distribution of the gas impermeable package 40 before use of the catheter 12 for a period of time sufficient: i) to form a 100% relative humidity atmosphere within the sealed gas impermeable package 40, and ii) for the hydrophilic outer surface of the catheter 12 to be hydrated so the catheter 12 is ready for use.
  • the reference numeral 62 designates generally an apparatus for performing certain steps of the method of manufacturing a urine collection assembly 10 in accordance with the present disclosure.
  • the apparatus 62 includes a receiving station 64 for the urine collection bag 22 and a receiving station 66 for the conventional catheter 12 wherein the urine collection bag 22 and the catheter 12 are placed in the respective receiving stations 64 and 66 as illustrated in Fig. 8A .
  • a station 68 which supports a mandrel 68a for the funnel 20 on the catheter 12 and which supports a positioning element 68b for the cylindrical attachment port 24 on the urine collection bag 22 is raised as shown in Fig. 8B .
  • a urine collection bag gripping element 70 is provided for gripping the urine collection bag 22 and a funnel gripping element 72 is provided for gripping the funnel 20 on the catheter 12 ( Fig. 8B ).
  • the gripping elements 70 and 72 undergo linear reciprocating movement between non-gripping positions ( Fig. 8A ) and positions in which they grip the urine collection bag 22 and the funnel 20 on the catheter 12, respectively ( Fig. 8B ).
  • the receiving station 66 and the gripping element 70 are each mounted for movement toward and away from the station 68 for reasons that will become clear in the description which follows.
  • the apparatus 62 is shown in a position after the gripping element 70 has moved the urine collection bag 22 toward the station 68 to a location where the positioning element 68b properly positions the cylindrical attachment port 24. It is also shown in a position after the receiving station 66 has moved the catheter 12 to properly position the funnel 20 on the mandrel 68a. At this point, the funnel gripping element 72 releases the funnel 20, the station 66 moves away from the station 68, and a second funnel gripping element 72a moves to grip the cylindrical barrel portion 18 of the funnel 20. Further, it will be noted that a cutting element 74 has been moved linearly from within a guard 76 to a position where it can cut off the conical portion 46 leaving only the cylindrical barrel portion 18 of the funnel 18 (see, also, Fig. 4 ).
  • the cutting element 74 is withdrawn into the guard 76 and the station 68 is dropped down (as shown in Fig. 8D ) for removal of the severed conical portion 46 of the funnel 20 from the mandrel 68a.
  • the station 66 is moved toward the station 64 (as shown in Fig. 8E ) until the cylindrical barrel portion 18 of the funnel 20 is disposed within the cylindrical attachment port 24 in size to size fashion.
  • the second funnel gripping element 72a grips the cylindrical barrel portion 18 of the funnel 20 to maintain it in a stationary position and a second urine collection bag gripping element 70a grips and spins both the cylindrical attachment port 24 and the urine collection bag 22 relative to the catheter 12 ( Fig. 8F ).
  • the second urine collection bag gripping element 70a grips and initiates the spinning of the cylindrical attachment port 24 and the urine collection bag 22 just before the cylindrical barrel portion 18 is inserted into the cylindrical attachment port 24 and, then, it accelerates to full speed after the cylindrical barrel portion 18 has been fully inserted.
  • the apparatus 62 is shown after spinning which completes the manufacture of the urine collection assembly 10.
  • the stations 64 and 66 are again in their starting positions to repeat the process.
  • the cylindrical barrel portion 18 is bonded to the cylindrical attachment port 24 by spin welding without the use of any adhesives or solvents.

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Claims (13)

  1. Verfahren zur Herstellung einer verpackten, gebrauchsfertigen Urinsammelanordnung (10), das die folgenden Schritte umfasst:
    Bereitstellen eines Katheters (12), der ein proximales Einschubende (14) und ein distales Ende (16) mit einem sich verjüngenden Trichter (20) aufweist, der einen zylindrischen Schaftabschnitt (18) und einen einstückig damit verbundenen konischen Abschnitt (46) beinhaltet, wobei der Katheter zudem eine hydrophile Außenfläche aufweist, die vor der Verwendung des Katheters zu hydratisieren ist;
    Abschneiden des konischen Abschnitts (46) des sich verjüngenden Trichters und Belassen nur des zylindrischen Schaftabschnitts (18) des sich verjüngenden Trichters, der einstückig mit dem distalen Ende des Katheters verbunden ist;
    Bereitstellen eines Urinsammelbeutels (22) mit einem zylindrischen Befestigungsanschluss (24), der eine Öffnung definiert, die so bemessen ist, dass sie den zylindrischen Schaftabschnitt (18) des sich verjüngenden Trichters in einer Weise je nach Größe aufnimmt;
    Anordnen des zylindrischen Schaftabschnitts (18) des sich verjüngenden Trichters in der Öffnung, die durch den zylindrischen Befestigungsanschluss des Urinsammelbeutels definiert ist, in einer Weise je nach Größe;
    Abdichten des zylindrischen Schaftabschnitts des sich verjüngenden Trichters innerhalb der Öffnung, die durch den zylindrischen Befestigungsanschluss des Urinsammelbeutels definiert ist;
    Bereitstellen einer gasundurchlässigen Verpackung (40), die den Katheter und den Urinsammelbeutel darin aufnehmen kann;
    Anordnen des Katheters, des Urinsammelbeutels und eines Hydratisierungsmittels in der gasundurchlässigen Verpackung (40); und
    Abdichten der gasundurchlässigen Verpackung (40) mit dem Katheter (12), dem Urinsammelbeutel (22) und dem Hydratisierungsmittel darin.
  2. Verfahren nach Anspruch 1, beinhaltend die Schritte des Bildens des Urinsammelbeutels (22) aus einem flexiblen Schichtmaterial und des Abdichtens des Befestigungsanschlusse in dem Schichtmaterial.
  3. Verfahren nach Anspruch 2, beinhaltend den Schritt des Verwendens von zwei Schichten aus EVA-/Polyethylenfolie für das flexible Schichtmaterial und Abdichten der zwei Schichten um deren Umfangskanten (32).
  4. Verfahren nach Anspruch 2, das einen koextrudierten Schlauch bereitstellt, der so gebildet ist, dass er eine EVA-Außenfläche und eine PVC-Innenfläche für den zylindrische Befestigungsanschluss (24) aufweist.
  5. Verfahren nach Anspruch 4, wobei der zylindrische Schaftabschnitt aus PVC gebildet ist und der Schritt des Abdichtens des zylindrischen Schaftabschnitts innerhalb der Öffnung durch Rotationsschweißen durchgeführt wird.
  6. Verfahren nach Anspruch 5, wobei der Rotationsschweißschritt durchgeführt wird, indem der Katheter (12) in einer stationären Position gehalten wird und der Urinsammelbeutel (22) relativ zu dem Katheter gedreht wird.
  7. Verfahren nach Anspruch 6, beinhaltend den Schritt des Bereitstellens des Urinsammelbeutels (22) in einer allgemein rechteckigen Form, des Faltens des Urinsammelbeutels mindestens einmal allgemein senkrecht zur Richtung des Katheters (12), des Durchführens des Rotationsschweißschritts, des Faltens des Urinsammelbeutels mindestens einmal in Richtung des Katheters und des Banderolierens des Urinsammelbeutels in einem gefalteten Zustand.
  8. Verfahren nach Anspruch 7, wobei der Rotationsschweißschritt das Drehen des Urinsammelbeutels (22) relativ zu dem Katheter (12) mit einer Drehgeschwindigkeit zwischen 1900 und 3000 U/min beinhaltet.
  9. Verfahren nach Anspruch 8, wobei der Rotationsschweißschritt das Drehen des Urinsammelbeutels (22) relativ zu dem Katheter (12) für 14 bis 16 Umdrehungen beinhaltet.
  10. Verfahren nach Anspruch 1, beinhaltend den Schritt des Bereitstellens einer Einführhilfe (26) an oder nahe dem proximalen Einschubende (14) des Katheters und einer Hülse (28), die den Katheter im Wesentlichen bedeckt.
  11. Verfahren nach Anspruch 1, beinhaltend den Schritt des Abdichtens eines Antirückflussventils (30) an dem zylindrischen Befestigungsanschluss (24) innerhalb des Urinsammelbeutels.
  12. Verfahren nach Anspruch 1, wobei das Hydratisierungsmittel flüssiges Wasser ist, und beinhaltend den Schritt des Isolierens des flüssigen Wassers von der hydrophilen Außenfläche des Katheters.
  13. Verfahren nach Anspruch 12, beinhaltend den Schritt des Verzögerns der Ausgabe der gasundurchlässigen Verpackung (40) zur Verwendung des Katheters für eine Zeitspanne, die ausreicht, um eine Atmosphäre mit 100 % relativer Feuchtigkeit innerhalb der abgedichteten gasundurchlässigen Verpackung zu bilden und die hydrophile Außenfläche zu hydratisieren, sodass der Kathether gebrauchsfertig ist.
EP12713441.9A 2011-03-25 2012-03-13 Urinsammelanordnung und verfahren zur herstellung einer solchen anordnung Active EP2688629B1 (de)

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US201161467679P 2011-03-25 2011-03-25
PCT/US2012/028862 WO2012134804A1 (en) 2011-03-25 2012-03-13 Urine collection assembly and method

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EP2688629B1 true EP2688629B1 (de) 2022-12-14

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DK2688629T3 (da) 2023-01-09
CA2831248C (en) 2017-04-04
EP2688629A1 (de) 2014-01-29
WO2012134804A1 (en) 2012-10-04
US20150105756A1 (en) 2015-04-16
HUE061305T2 (hu) 2023-06-28
LT2688629T (lt) 2023-01-10
AU2012238104A1 (en) 2013-10-10
CA2831248A1 (en) 2012-10-04

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